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Active, not recruitingNCT03465254Updated May 17, 2023

Dengue Serostatus Study in the Philippines

An observational study in Dengue, Severe Dengue and Dengue Fever, sponsored by University of the Philippines. Active, not recruiting. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by University of the Philippines · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,996
Ages
9 Years to 14 Years
Sex
All
01

Study summary

This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.

Read the detailed description

This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with \<5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.

02

Conditions studied

  • Dengue
  • Severe Dengue
  • Dengue Fever
  • Virologically-confirmed Dengue
03

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children in selected study areas in Region 7, aged 9-14 years old who are considered eligible to be included in the DOH dengue mass vaccination

Inclusion criteria

  • Provide signed informed consent and assent (as applicable)
  • Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization
  • Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017

Exclusion criteria

Exclusion criteria:

  • Any subject whose parent/guardian refuse to provide informed consent and/or assent
  • Children who do not belong to the specified age groups and not residents of the targeted communities
  • Children \<9 years old
  • Children with history of bleeding disorder
  • Any subject previously enrolled in a dengue vaccine clinical trial
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,996 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort

    Recruited members of the cohort are children aged 9-14 years old and eligible to receive the dengue vaccine at the time of the initiation of community-based dengue immunization program of the Department of Health.

05

What researchers measure

Primary outcomes

  1. virologically-confirmed dengue (VCD)

    The primary outcome measure is virologically confirmed dengue by RT-PCR

    Time frame: 5 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Lopez AL, Adams C, Ylade M, Jadi R, Daag JV, Molloy CT, Agrupis KA, Kim DR, Silva MW, Yoon IK, White L, Deen J, de Silva AM. Determining dengue virus serostatus by indirect IgG ELISA compared with focus reduction neutralisation test in children in Cebu, Philippines: a prospective population-based study. Lancet Glob Health. 2021 Jan;9(1):e44-e51. doi: 10.1016/S2214-109X(20)30392-2. Epub 2020 Nov 16. PubMed 33212030 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03465254
Lead sponsor
University of the Philippines
Collaborators
Department of Health, Philippines, World Health Organization, Research Institute for Tropical Medicine, Philippines, University of North Carolina, La Jolla Institute for Allergy & Immunology, International Vaccine Institute
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Nov 2016
Primary completion
Oct 31, 2022
Completion
Jun 2023 (estimated)
Last update
May 17, 2023

Study contacts

Jacqueline L. Deen, MD
principal investigator · UPM-NIH, Institute of Child Health and Human Development

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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